Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:58 AM
Study NCT ID:
NCT07463066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Effectiveness of Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'Baseline', 'description': 'Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Baseline', 'description': "Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome."}, {'measure': 'Survey of Pain Attitudes', 'timeFrame': 'Baseline', 'description': 'Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results.'}, {'measure': 'Female Sexual Function Index', 'timeFrame': 'Baseline', 'description': 'Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Pelvic pain', 'Dysfunction sexual'], 'conditions': ['Genito-Pelvic Pain/Penetration Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this observational follow-up study is to learn whether the benefits of Pain Neuroscience Education are maintained five years after the original intervention in women previously diagnosed with Genito-Pelvic Pain/Penetration Disorder who participated in a randomized controlled trial.\n\nThe main questions it aims to answer are:\n\nAre improvements in pain intensity maintained five years after the intervention? Are improvements in sexual function and pain-related disability sustained over time?\n\nResearchers will compare participants according to the treatment group to which they were originally assigned in the randomized controlled trial to evaluate long-term differences in outcomes.\n\nParticipants will:\n\nComplete questionnaires assessing pain intensity, sexual function, and pain-related outcomes. Undergo follow-up assessments similar to those performed during the original study.', 'detailedDescription': 'Genito-Pelvic Pain/Penetration Disorder is a chronic pain condition that significantly affects physical, emotional, and sexual well-being. Women experiencing persistent pelvic pain frequently report difficulties related not only to pain intensity but also to sexual function, fear of movement or penetration, and reduced quality of life. Despite its high impact, conservative treatment approaches remain underutilized, and long-term management strategies are still being explored.\n\nPain Neuroscience Education (PNE) has emerged over the last decade as a therapeutic approach aimed at helping patients understand the neurophysiological mechanisms underlying persistent pain. By reconceptualizing pain as a multifactorial and modifiable process rather than solely a marker of tissue damage, PNE seeks to reduce fear, maladaptive beliefs, and pain-related disability. Growing evidence supports its short- and medium-term effectiveness in various chronic pain populations.\n\nFive years ago, a multi-centered randomized controlled trial evaluated the effectiveness of a structured Pain Neuroscience Education program in women diagnosed with Genito-Pelvic Pain/Penetration Disorder. The intervention was delivered through different educational modalities and demonstrated clinically relevant improvements following treatment.\n\nHowever, evidence regarding the durability of these effects over extended periods remains limited. Long-term follow-up studies are essential to determine whether educational interventions targeting pain processing produce sustained changes in pain perception, functional outcomes, and overall well-being.\n\nThe present study is designed as a long-term observational follow-up of the original randomized controlled trial cohort. No new intervention will be administered. Instead, participants who were previously enrolled will be reassessed five years after completion of the initial intervention in order to evaluate the persistence of treatment-related changes over time.\n\nThis study will contribute to understanding the long-term trajectory of women treated with Pain Neuroscience Education for persistent pelvic pain and will help clarify the potential role of educational strategies as durable components of conservative pain management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be selected from the cohort of women previously enrolled in a randomized controlled trial evaluating Pain Neuroscience Education for Genito-Pelvic Pain/Penetration Disorder. The source population consists of adult women diagnosed with Genito-Pelvic Pain/Penetration Disorder who were originally recruited from clinical settings for the parent study.\n\nEligible participants are women aged 18 years or older who are able to read and understand Spanish and provide informed consent. The population includes individuals with varying demographic and clinical characteristics, such as age, marital status, duration of symptoms, pain severity, and baseline functional status. All participants completed the original intervention protocol and will be contacted for long-term follow-up assessment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients over 18 years-old suffering from dyspareunia for more than 3 months\n\nExclusion Criteria:\n\n\\- Patients suffering from a previous medical condition that explains logically the presence of pain'}, 'identificationModule': {'nctId': 'NCT07463066', 'briefTitle': 'Long-Term Effectiveness of Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Long-Term Outcomes at Five Years Following Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder: Observational Follow-Up of a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'UV-INV_ETICA-1741806-FU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In person workshops', 'description': 'This group will attend in person workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites.', 'interventionNames': ['Other: In person workshops']}, {'label': 'Online-accessed material', 'description': 'This group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content.', 'interventionNames': ['Other: Online-accessed material']}, {'label': 'Control group', 'description': 'This group will initially no recieve an intervention and will serve as a control group.'}], 'interventions': [{'name': 'In person workshops', 'type': 'OTHER', 'description': 'Several in person workshops given by a researcher', 'armGroupLabels': ['In person workshops']}, {'name': 'Online-accessed material', 'type': 'OTHER', 'description': 'Access to a website containing the educational program', 'armGroupLabels': ['Online-accessed material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Faculty of Physiotherapy. University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Borja Perez-Dominguez, PhD.', 'role': 'CONTACT', 'email': 'f.borja.perez@uv.es', 'phone': '+34 697464680'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Borja Pérez-Domínguez', 'investigatorAffiliation': 'University of Valencia'}}}}